Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
560Conditions
CancerSummary
This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.
Detailed Description
Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes.
This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.
Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator’s primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.
Locations
1 location Found with status Recruiting
Eligibility Criteria
Inclusion Criteria:
* 18 years of age or older
* Speak and understand English
* Male or Female
* A personal history of one or more of the following:
* metastatic breast cancer
* advanced ovarian cancer (Stage III-IV)
* metastatic pancreatic cancer
* metastatic prostate cancer
* Naive to previous cancer germline genetic testing
Exclusion Criteria:
* Communication difficulties such as:
* Uncorrected or uncompensated hearing and/or vision impairment
* Uncorrected or uncompensated speech defects
* Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
Study Plan
ARM A
EXPERIMENTAL
Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).nnVisit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).
OTHER:
Standard of CareDescription:
Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
ARM B
EXPERIMENTAL
Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).nnVisit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.
OTHER:
Standard of CareDescription:
Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)OTHER:
Post-Test InterventionDescription:
Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
ARM C
EXPERIMENTAL
Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.nnVisit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor either in-person or by remote services (Telephone or Video Conferencing).
OTHER:
Pre-Test InterventionDescription:
Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.OTHER:
Standard of CareDescription:
Standard of Care with a Genetic Counselor either In-Person or by Remote Services (Telephone or Video Conferencing)
ARM D
EXPERIMENTAL
Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.nnVisit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.
OTHER:
Pre-Test InterventionDescription:
Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.OTHER:
Post-Test InterventionDescription:
Secure and accessable by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
Outcome Measures
Primary Outcome Measures
Change in Knowledge
Change in Anxiety
Secondary Outcome Measures
Change in Depression
Change in Cancer Specific Distress
Change in Uncertainty
Change in Health Behaviors
Provider Time
Provider Time
Frequency of Uptake of Testing
Timeline
Last Updated
July 30, 2024Start Date
April 21, 2020Today
February 5, 2025Completion Date ( Estimated )
December 31, 2025
Sponsors of this trial
Lead Sponsor
Abramson Cancer Center at Penn MedicineCollaborating Sponsors
AstraZeneca, Fox Chase Cancer Center, Basser Center for BRCA, Merck Sharp & Dohme LLC
RECRUITING 
21 - 64 Years